EP4299585A3 - Compositions and methods for anti-thrombotic and hemostatic therapies - Google Patents

Compositions and methods for anti-thrombotic and hemostatic therapies Download PDF

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Publication number
EP4299585A3
EP4299585A3 EP23192817.7A EP23192817A EP4299585A3 EP 4299585 A3 EP4299585 A3 EP 4299585A3 EP 23192817 A EP23192817 A EP 23192817A EP 4299585 A3 EP4299585 A3 EP 4299585A3
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EP
European Patent Office
Prior art keywords
subject
blood sample
fviii
amount
bleeding risk
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23192817.7A
Other languages
German (de)
French (fr)
Other versions
EP4299585A2 (en
Inventor
Zaverio RUGGERI
Wolfram Ruf
Yuichi Kamikubo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Scripps Research Institute
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Scripps Research Institute
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Filing date
Publication date
Application filed by Scripps Research Institute filed Critical Scripps Research Institute
Publication of EP4299585A2 publication Critical patent/EP4299585A2/en
Publication of EP4299585A3 publication Critical patent/EP4299585A3/en
Pending legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424—Serine endopeptidases (3.4.21)
    • C12N9/644—Coagulation factor IXa (3.4.21.22)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/86—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood coagulating time or factors, or their receptors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/50—Determining the risk of developing a disease
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • General Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Cell Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Physics & Mathematics (AREA)
  • Diabetes (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)

Abstract

In various embodiments, disclosed herein are assays for measuring thrombin generated (TG) in a blood sample, comprising: incubating the blood sample with TF, FIXa, and CaCl2; and measuring TG in the blood sample. Also disclosed herein are assays for determining a bleeding risk in a subject, comprising obtaining a blood sample from the subject; adding to the blood sample TF and/or FIXa; determining the amount of coagulation factor VIII (FVIII:C) in the blood sample; and determining (a) a mild bleeding risk in the subject if the amount of FVIII:C in the sample is >5 IU/dL, (b) a moderate bleeding risk in the subject if the amount of FVIII:C in the sample is 1-5 IU/dL, and (c) a severe bleeding risk in the subject if the amount of FVIII:C in the subject is <1 IU/dL.
EP23192817.7A 2016-05-13 2017-05-12 Compositions and methods for anti-thrombotic and hemostatic therapies Pending EP4299585A3 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662336264P 2016-05-13 2016-05-13
EP17796981.3A EP3455636B1 (en) 2016-05-13 2017-05-12 Compositions and methods for anti-thrombotic and hemostatic therapies
PCT/US2017/032514 WO2017197332A1 (en) 2016-05-13 2017-05-12 Compositions and methods for anti-thrombotic and hemostatic therapies

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
EP17796981.3A Division EP3455636B1 (en) 2016-05-13 2017-05-12 Compositions and methods for anti-thrombotic and hemostatic therapies

Publications (2)

Publication Number Publication Date
EP4299585A2 EP4299585A2 (en) 2024-01-03
EP4299585A3 true EP4299585A3 (en) 2024-04-17

Family

ID=60266811

Family Applications (2)

Application Number Title Priority Date Filing Date
EP17796981.3A Active EP3455636B1 (en) 2016-05-13 2017-05-12 Compositions and methods for anti-thrombotic and hemostatic therapies
EP23192817.7A Pending EP4299585A3 (en) 2016-05-13 2017-05-12 Compositions and methods for anti-thrombotic and hemostatic therapies

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP17796981.3A Active EP3455636B1 (en) 2016-05-13 2017-05-12 Compositions and methods for anti-thrombotic and hemostatic therapies

Country Status (5)

Country Link
US (2) US11136370B2 (en)
EP (2) EP3455636B1 (en)
JP (3) JP6772298B2 (en)
ES (1) ES2959277T3 (en)
WO (1) WO2017197332A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL2019854B1 (en) 2017-11-06 2019-05-13 Good Biomarker Sciences B V Method for determining Factor Xa inhibitor dosage
WO2020163685A1 (en) * 2019-02-07 2020-08-13 Portola Pharmaceuticals, Inc. Methods for treating intracranial hemorrhage and assessing efficacy
JP6883899B1 (en) * 2020-12-07 2021-06-09 株式会社血栓トランスレーショナルリサーチラボ Blood coagulation test reagent and blood coagulation test method
EP4270010A1 (en) * 2020-12-28 2023-11-01 Fujimori Kogyo Co., Ltd. Method for evaluating blood coagulation performance, and method for inspecting risk of thrombosis
JP7152084B1 (en) * 2022-02-22 2022-10-12 株式会社血栓トランスレーショナルリサーチラボ Test Reagent, Test Reagent Set, and Test Method for Anticoagulant Activity of Tissue Factor Pathway Inhibitor

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002034109A2 (en) * 2000-10-27 2002-05-02 Biomerieux, Inc A reagent and kit for determining global coagulability and hemostatic potential
AU2006200265A1 (en) * 1998-03-19 2006-02-09 Instrumentation Laboratory S.P.A. Screening for blood coagulation defects using metal ions
WO2015066700A2 (en) * 2013-11-04 2015-05-07 The Regents Of The University Of California Therapy for treatment or prevention of conditions associated with bleeding or hypocoagulation

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005017486A2 (en) 2003-06-09 2005-02-24 Mann Kenneth G A global test of the hemostatic system
US20050221414A1 (en) * 2004-03-31 2005-10-06 Katalin Varadi Kit for measuring the thrombin generation in a sample of a patient's blood or plasma
US20090298108A1 (en) 2005-02-28 2009-12-03 Joachim Schultz Method for Identifying PDE11 Modulators
WO2009142744A2 (en) 2008-05-20 2009-11-26 The University Of Vermont And State Agriculture College Predicting hemostatic risk; dependence on plasma composition
WO2013141965A1 (en) * 2012-03-21 2013-09-26 Baxter International Inc. Tfpi inhibitors and methods of use
FR3001729B1 (en) * 2013-02-04 2015-03-06 Lab Francais Du Fractionnement FACTOR X MUTANTS
CN105829888B (en) 2013-12-19 2019-08-06 皇家飞利浦有限公司 Method for determining the hemostatic risk of object
ES2907190T3 (en) 2014-07-31 2022-04-22 Haemonetics Corp Detection of anticoagulant reversal by ecarin and factor Xa coagulation tests
JP6883899B1 (en) * 2020-12-07 2021-06-09 株式会社血栓トランスレーショナルリサーチラボ Blood coagulation test reagent and blood coagulation test method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2006200265A1 (en) * 1998-03-19 2006-02-09 Instrumentation Laboratory S.P.A. Screening for blood coagulation defects using metal ions
WO2002034109A2 (en) * 2000-10-27 2002-05-02 Biomerieux, Inc A reagent and kit for determining global coagulability and hemostatic potential
WO2015066700A2 (en) * 2013-11-04 2015-05-07 The Regents Of The University Of California Therapy for treatment or prevention of conditions associated with bleeding or hypocoagulation

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
MCINTOSH: "A modified thrombin generation test for the measurement of factor VIII concentrates - Mcintosh - 2003 - Journal of Thrombosis and Haemostasis - Wiley Online Library", 1 January 2003 (2003-01-01), XP055635569, Retrieved from the Internet <URL:https://onlinelibrary.wiley.com/doi/epdf/10.1046/j.1538-7836.2003.00209.x> [retrieved on 20191024] *
NINIVAGGI: "Thrombin generation assay using factor IXa as a trigger to quantify accurately factor VIII levels in haemophilia A - NINIVAGGI - 2011 - Journal of Thrombosis and Haemostasis - Wiley Online Library", 1 January 2011 (2011-01-01), XP055635547, Retrieved from the Internet <URL:https://onlinelibrary.wiley.com/doi/epdf/10.1111/j.1538-7836.2011.04358.x> [retrieved on 20191024] *
UNKNOWN: "COATEST SP FVIII -82 4086 63 ENGLISH -Insert revision 02/2016 COATEST SP FVIII -82 4086 63", 1 February 2016 (2016-02-01), XP093122063, Retrieved from the Internet <URL:https://diapharma.com/wp-content/uploads/2023/05/K824086-Chromogenix-Coatest-SP-FVIII-Insert-303413-Rev-R4-02-2016-1.pdf> [retrieved on 20240122] *

Also Published As

Publication number Publication date
JP2022058539A (en) 2022-04-12
WO2017197332A1 (en) 2017-11-16
EP3455636B1 (en) 2023-08-23
JP6772298B2 (en) 2020-10-21
US20190127442A1 (en) 2019-05-02
EP4299585A2 (en) 2024-01-03
EP3455636A1 (en) 2019-03-20
JP7091413B2 (en) 2022-06-27
EP3455636A4 (en) 2020-03-25
JP2021021737A (en) 2021-02-18
JP2019521324A (en) 2019-07-25
ES2959277T3 (en) 2024-02-22
US11136370B2 (en) 2021-10-05
US20210395341A1 (en) 2021-12-23

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